Device and method for performing multiple anastomoses

ABSTRACT

Methods and devices for creating a seal in a vessel for performing multiple anastomoses. The device includes an expandable region at the shaft assembly distal end with a sealing membrane that spans the expandable region, and a corresponding clamping member moveable toward the expandable region. Once inserted into the vessel lumen the expandable region is deployed from a first low-profile position into a second expanded position, and positioned at the target site of the anastomoses. Movement of the distal end of the clamping member, which remains located outside the vessel, against the expanded region creates a seal at the target site allowing a blood-free, graft site area that is large enough to accommodate multiples anastomoses.

BACKGROUND OF THE INVENTION

The present invention relates to the fields of vascular andcardiovascular surgery, and more particularly to methods and devices forobtaining hemostatic sealing when performing graft procedures.

Vascular and cardiovascular grafting procedures typically require thecomplete, or at least partial, occlusion of a selected vessel. Forexample, in the field of cardiovascular surgery, coronary artery bypassgraft (CABG) procedures involving proximal anastomosis require the full,or at least partial, occlusion of the aorta. During proximalanastomosis, a vein or arterial graft is sewn to the aorta forrevascularization of diseased or otherwise compromised coronaryarteries. The internal mammary artery and radial artery of the arm arealso used as bypass vessels. Occlusion of the aorta is typicallyaccomplished by clamping. A variety of clamp configurations are incommon use, including crossclamps for partial occlusion procedures. Forprocedures involving cardiopulmonary bypass, full aortic occlusion isrequired. Partial occlusion is used in either on or off-pump coronaryartery bypass graft procedures for proximal anastomosis. Occlusion ofthe aorta prevents blood flow from entering the graft target site,creating a bloodless field for the surgeon to then sew the graft to theaorta. Once the graft is sewn to the aorta, the surgeon removes theclamp, once again allowing blood flow to the anastomotic region.

Unfortunately, injury resulting from such clamping can be significant.Such injuries include, but are not limited to, intimal hyperplasia,thrombosis (which may progress to total occlusion), embolism, intimaltears and flaps, mural dissections, aneurysms, arterial rupture,through-and through injury, and arterio-venous fistulae. As just oneexample, neurologic morbidity after cardiac surgery has been associatedwith particulate embolization. Crossclamp manipulation has beenidentified as the single most significant cause of particulate embolirelease during cardiac surgery. Therefore, surgeons would prefer toeliminate the use of clamps during coronary artery bypass graftprocedures in order to minimize adverse events and improve outcomes.

Efforts have been made to devise alternative devices and methods forperforming bypass graft procedures that avoid complete clamping orcrossclamping of the aorta. For example, U.S. Pat. No. 5,477,515describes a bypass clamp with a spoon-shaped blade insertable through anincision in the aorta. Patches of saphaneous vein or other substituteare sutured on either side of the incision to reinforce the aorta andprevent tearing or abrasion by the clamp. U.S. Pat. No. 5,944,730describes a device for creating a seal at an incision that includes atube with a translatable shaft connected to a flexible inverting member.The inverting member is inserted into the incision and proximal forceapplied to the device creates a seal. Other methods have relied uponinflatable devices for partially occluding a vessel without interruptingblood flow. U.S. Pat. No. 6,143,015 describes such a device whichincludes first and second inflatable spaced apart members interconnectedby a tubular connector that allows for blood flow.

WO 02/067787 describes a device having a low-profile shaft assembly thatcan be inserted into the lumen of a vessel with an expandable regionthat can be deployed into an expanded position. Movement of acorresponding clamping member which remains located outside the vesselagainst the expanded region creates a seal at the target site forperforming an anastomosis procedure.

There remains a need for improved devices and methods for performinganastomosis procedures, including devices and methods that facilitateperforming multiple anastomoses in a simple, reliable and convenientfashion.

SUMMARY OF THE INVENTION

The present invention meets the above needs and achieves furtheradvantages by providing for improved devices and methods for performinganastomosis procedures, including multiple anastomoses.

In an aspect of the invention, methods and devices are provided forcreating a seal at a target anastomosis site in a blood vessel. Themethods and devices include the use of a low profile shaft assemblyconfigured for insertion into a blood vessel, the shaft assembly furtherhaving an expandable region and a sealing membrane spanning theexpandable region, with the expandable region being deployable from afirst low-profile position to a second expanded position. Methods ofusing the assembly include inserting the assembly into the desired bloodvessel and positioning the expandable region at the target anastomosissite, then deploying the expandable region from said first low-profileposition to said second expanded position and engaging the inner wall ofthe blood vessel at the target anastomosis site with the expandableregion in its second expanded position to create a seal at the targetanastomosis site. In variations of methods according to the invention,an anastomosis procedure is then performed at the sealed anastomosissite. Multiple anasotomoses can be performed by repositioning theexpandable region at subsequent target sites, without withdrawing theshaft assembly from the vessel.

In another aspect of the invention, methods and devices are provided forperforming multiple anastomoses that include the use of a sealing memberdeployable from a first low-profile position to a second expandedposition. The sealing member is similarly introduced into a bloodvessel, deployed its first low-profile position to said second expandedposition, and engaged with the inner wall of the blood vessel at adesired location to create a seal. The sealing member is furtherconfigured such that sealed area of the blood vessel is large enough toaccommodate multiple ansastomoses.

In other aspects of the invention, the deployment of shaft assemblies orsealing members according to the invention can be remotely actuated.

In a further aspect of the invention, a device for creating a seal in ablood vessel is provided having a low profile shaft assembly configuredfor insertion into a vessel, the shaft assembly having an expandableregion at the distal end of the shaft assembly and a sealing membranespanning the expandable region, with the expandable region beingdeployable from a first low-profile position to a second expandedposition. The device also includes a clamping member positionedgenerally opposite to and moveable towards said expanding region, saidclamping member having a distal end shape corresponding to saidexpanding region in its second expanded position. That is, the distalend corresponds in shape to the expanded region to a sufficient degreesuch that when expanded region is deployed within a blood vessel and theexpanded region and clamping member region are compressed together, theinner wall of the blood vessel contained by the expanded region issealed-off from continuing blood flow within the vessel. In furthervariations of the invention, the expanded region can correspond to asurface area of the blood vessel that is large enough to accommodatemultiple anastomosis sites, allowing for performance of multipleanastomoses with a single deployment of the device. In other variationsof the invention, the expanded region of the device can include avariety of shapes, including hexagonal, octagonal, oval, circular andthe like.

In other variations, the expandable region of devices according to theinvention further include segments that bow outwardly from the shaftassembly when the expandable region is deployed from said firstlow-profile position to said second expanded position. These bowingsegments can further be biased toward the clamping member, to aid inefficacy of sealing. The bowing segments can be formed, e.g., of aslitted flexible tube or a super-elastic shape memory alloy.

In further variations of invention, the shaft assembly of devicesaccording to the invention can be operably linked to a slide such thattranslational movement of the slide deploys the expandable region of theshaft assembly from its first low-profile position to its secondexpanded position. In other variations, a deployment tube moveable inrelationship to the expandable region is provided such thattranslational movement of expandable region from deployment tube deploysthe expandable region from its first low-profile position to its secondexpanded position.

In other variations of the invention, the integrity of the sealingmembrane is protected or enhanced as a precaution against inadvertenttearing or puncture of the deployed sealing membrane during ananastomosis procedure. For example, the sealing membrane itself can bereinforced, or a protective shield can be provided that is deployableover the sealing membrane.

In yet another variation of the invention, the expandable region in itssecond expanded position can have a cup-shaped configuration, such thatwhen in use it creates a sealed- off region around the rim of thecup-shaped configuration, with increased depth that allows for a largerworkspace for performing the anastomosis procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a device according to one embodiment ofthe invention, with the device in an open, non-sealing position and theexpandable region of the shaft assembly of the device in an unexpandedposition;

FIG. 2 is a perspective view of the device of FIG. 1, with theexpandable region shaft assembly of the device in its deployed, expandedposition;

FIG. 3 is a perspective view of the device of FIG. 1 in a sealingposition, with the expandable region shaft assembly of the device in itsdeployed, expanded position and the clamping member moved toward theshaft assembly;

FIG. 4 is a side view of the device of FIG. 1, with parts broken away,in the open, non-sealing position as shown in FIG. 1;

FIG. 5 is a side view of the device of FIG. 1, with parts broken away,in the sealing position as shown in FIG. 3;

FIG. 6 is a sectional view of the device of FIG. 1 in the open,non-sealing position as shown in FIG. 1;

FIG. 7 is a sectional view of the device of FIG. 1 in the sealingposition as shown in FIG. 3;

FIGS. 8A-8C are top (FIG. 8A), side (FIG. 8B) and bottom (FIG. 8C) viewsof the shaft assembly of the device of FIG. 1 in its unexpandedposition;

FIG. 8D is a top view of the shaft assembly of the device of FIG. 1 inits deployed, expanded position;

FIG. 8E is a front view of the shaft assembly of the device of FIG. 1 inits deployed, expanded position;

FIG. 9 is a perspective view of the slide of the device of FIG. 1 thatis operably linked to the shaft assembly for deploying the expandableregion of the shaft assembly into its expanded position;

FIGS. 10A and 10B are perspective views of the slide actuator of thedevice of FIG. 1 that engages the slide shown in FIG. 9;

FIG. 11 is a perspective view of the device of FIG. 1, with parts brokenaway, showing the slide, slide actuator and shaft assembly;

FIG. 12 is a perspective view of the device of FIG. 1 together with atool for remote actuation of the device;

FIG. 13 is a top view of a shaft assembly of a device according toanother embodiment the invention its deployed, expanded position;

FIG. 14 is a top view of a shaft assembly of a device according to yetanother embodiment the invention its deployed, expanded position;

FIG. 15 is a perspective view of a device according to an embodiment ofthe invention in use to create a seal in a blood vessel for performingmultiple anastomoses;

FIG. 16 is a perspective view of a shaft assembly of a device accordingto a further embodiment of the invention in its non-deployed position;

FIG. 17 is a perspective view of a shaft assembly of FIG. 16 in itsdeployed, expanded position;

FIGS. 18A and 19A are top and sectional views, respectively, of a shaftassembly of a device according to a yet another embodiment of theinvention in its non-deployed position, with FIG. 19A taken along planeA-A of FIG. 18A;

FIGS. 18B and 19B are top and sectional views, respectively, of theshaft assembly of the device of FIGS. 18A and 19A, in its deployed,expanded position, with FIG. 19B taken along plane A-A of FIG. 18B;

FIGS. 20A and 21A are top and sectional views, respectively, of a shaftassembly of a device according to a yet another embodiment of theinvention in its non-deployed position, with FIG. 21A taken along planeB-B of FIG. 20A; and

FIGS. 20B and 21B are top and end views, respectively, of the shaftassembly of the device of FIGS. 20A and 20A, in its deployed, expandedposition, with FIG. 21B taken along plane B-B of FIG. 20B.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-11 depict one embodiment of a device according to the presentinvention. Device 10 includes shaft assembly 40 and clamping member 30extending from housing 20. As more clearly seen in FIGS. 6-7, Shaftassembly 40 includes control rod 41 disposed within flexible tube 50,with slide 62 being secured to the proximal end 47 of the rod thatresides within housing 20. Slide 62 is disposed within housing 20 and ismoveable along track 27 from a first to a second position relative tothe housing. As seen more clearly in FIGS. 4-5, clamping member 30 ispivotally mounted to the housing at pivot 31. Clamping member 30includes arm 34 that extends from housing 20 and terminates at itsdistal end in forks 36 and 37. Slide actuator 80 and clamping memberactuator 70 are operably linked to slide 62 and clamping member 30,respectively, as is further described.

As shown in FIGS. 6-7, control rod 41 of shaft assembly 40 is surroundedby flexible tube 50. Control rod 41 is preferably formed of rigidbiocompatible material, such as stainless steel. Flexible tube 50 ispreferably made of a plastic, such as Hytrel™, having a durometer in therange of 60-90 Shore D and a length between 1″ and 3″. As furtherdepicted in FIGS. 8A-8D, Holes 53 and 54 extend through the top of tube50 at its distal end, with hole 54 being proximal to hole 53, whileholes 56 and 57 extend through the bottom of tube 50, with hole 56 beingslightly distal to hole 53 and hole 57 slightly proximal to hole 54.Slot 55 extends through the tube, spanning from distal holes 53 and 56to proximal holes 54 and 57. Notches 58 and 59, which also extendthrough tube, are located along slot 55 roughly one-third and two-thirdsof the way between holes 53, 56 and holes 54, 57. Distal tip 46 ofcontrol rod 41, which remains located inside the flexible tube, ispermanently fixed to the distal tip of flexible tube 50, but theremainder of the flexible tube is free to move axially relative to shaftassembly 40. Proximal end 49 of flexible tube 50 is received withinhousing 20 through opening 25 and terminates at stop 26, as shown.Flexible tube 50 is rigidly secured to housing 20 by bosses in thehousing (not shown) that fit corresponding holes provided on theflexible tube (not shown). Alternatively, flexible tube 50 can otherwisebe secured to housing 20, or can abut up against the housing. Sealingmembrane 60 extends along at least that part of the flexible tube thatincludes through slot 55. Alternatively, the sealing membrane can beformed of a split tube that surrounds that part of the flexible tube,with the split portion of the tube coinciding with slot 55. The sealingmembrane can be formed of a variety of elastomers, including silicone.In the depicted embodiment, the thickness of the membrane can be between0.008″ to 0.015″, with the overall diameter of the shaft assembly is inthe range of 0.070″ to 0.110″, and the overall dimensions of the devicebeing 3.5×3.5×0.4″ or less. One skilled in the art will appreciate thatthe dimensions can be varied to optimize performance based on thedimensions of the particular vessel to be occluded.

FIGS. 1, 4 and 6 depict device 10 in an open, non-sealing position, withshaft assembly 40 in a low-profile, non-expanded position, while FIG. 2depicts the shaft assembly deployed to its expanded position. FIGS. 3, 5and 7 depict the device in its closed, sealing position, with the shaftassembly deployed in its expanded position and clamping member arm 34and forks 36 and 37 moved toward the shaft assembly. As shown moreclearly in FIGS. 4-7, lateral movement of slide 62 causes deployment ofthe shaft assembly from its low-profile, non-expanded position to itsdeployed, expanded position. Specifically, lateral translationalmovement of slide 62 away from the distal end of the shaft assemblyresults in lateral displacement of control rod 41. Displacement ofcontrol rod 41 forces distal tip 48 of flexible tube 50 to likewisedisplace. Proximal end 49 of flexible tube 50, however, is restrained inhousing 20, so that continued displacement of the control rod causesportions 56 and 57 of the flexible tube to bow outwardly to accommodatethe displacement of the distal tip, as seen in FIGS. 2, 3, 5 and 7. Theprovision of holes 53, 56 and 54, 57, and notches 58 and 59 weakens therelative rigidity of those corresponding regions of the tube, providingnatural flex points along the two sides of the split portion of thetube, which allow for bowing portions 51 and 52 to bow outwardly fromthe control rod. Notches 58 and 59 are further configured to ensureformation of a hexagonal pattern. The sides of each are cut to form anangle of approximately 39 degrees. As the bowing portions moveoutwardly, the sides of the notches come into contact with one another,maintaining the bowing portions at prescribed angles to form a hexagon.(See FIGS. 8A-8D). Further, as has been noted, distal holes 53 and 56are offset from one another as are proximal holes 54 and 57, with hole54 being slightly distal to hole 53 and whole 57 being slightly proximalto hole 56. This offset contributes to a slight upward biasing of thebowing portions in the direction of the opposing forks of the clampingmember, as further depicted e.g. in FIGS. 5, 7 and 8E. As will bedetailed further, this biasing of the bowing portions toward theclamping member forks provides for improved sealing of the device inoperation. As also seen in e.g. FIGS. 2, 3, 5 and 7, as the bowingportions expand outwardly, elastomeric sealing membrane 60 stretches toform a relatively planar sheet spanning the now expanded hexagonalregion of the distal end of the shaft assembly. As more clearly shown ine.g. FIG. 3, membrane 60 is adhered to the flexible tube 50 andstretches across the underside of the expanded region, opposite clampingmember forks 36, 37. As will be detailed further, in operation, thiscreates a working space between the sealed-off inner wall of a vesseland the membrane itself that is advantageous.

As noted, clamping member 30 is pivotally mounted to housing 20. Asshown more clearly in FIGS. 4-5, the clamping member pivots around pivotpin 31 which is received in a corresponding groove (not shown) withinthe housing. As shown e.g. in FIGS. 2-3, arm 34 of clamping member 30extends from the housing through opening 24. Forks 36 and 37 extend fromarm 34 to form a shape that generally corresponds to that of theexpanded hexagonal region of the distal end of the shaft assembly. Theforks 36 and 37 of clamping member 30 are further positioned relative tothe distal end of the shaft assembly such that when the arm is pivotedtoward the shaft, the forks can come into contact the expanded hexagonalregion. While forks 36 and 37 are depicted as likewise forming ahexagonal region, other corresponding shapes, e.g., circular shapes,will also suffice as long as such shapes correspond the expanded regionshape to a sufficient degree such that when expanded region is deployedwithin a blood vessel and the expanded region and clamping member regionare compressed together, the inner wall of the blood vessel contained bythe expanded region is sealed-off from continuing blood flow within thevessel.

In operation, when the shaft assembly 40 is deployed into a vessel andforks 36 and 37 of clamping member 30 are compressed against theexpanded region from the outside of the vessel, a seal is created at theclamp site. Further, by having the seal created by the membrane beingstretched only across the underside of the expanded region, a smallspace is created between the clamped vessel wall and the stretchedmembrane. The provision of this space is advantageous to the surgeon,facilitating grafting procedures with less risk of puncturing the sleeveand breaking the seal. The slight upward bias of bowing portions 51 and52 toward clamp forks 36 and 37 aids in the formation of a tight seal.In sealing operation, the bowing portions engage against the interiorvessel wall opposite the clamping forks on exterior of the vessel. Thecompressive force applied to keep the bowing portions in place andcreate the seal can cause the bowing portions to deflect slightly, butby having bowing portions initially biased toward the clamping forks, acertain amount of deflection can be accommodated while still maintaininga good seal and avoiding any undesirable leakage.

As seen e.g. in FIGS. 4-7, device 10 includes separate actuatingmechanisms for deploying the distal end of shaft assembly 40 into itsexpanded configuration and for moving clamping member 30 toward shaftassembly 40. Clamping member 70 and slide actuator 80 are independentlyoperable. Slide actuator 80 includes head 82, shaft 81 and dial 84, andis rotatably mounted within housing 20. Shaft 81 is oriented in thehousing perpendicular to shaft assembly 40. Dial 84 extends radiallyfrom shaft 81, with portions of the dial extending from housing 20 oneither side of the housing at opening 19. Head 82 is received in andextends from recessed seat 21 of housing 20 and collar 29 of housing 20receives shaft 81. Seat 21 and collar 29 maintain slide actuator 80 inplace while allowing it to freely rotate. Dial 84 is further providedwith underside recess 85 and pin 86 extending into the recess, moreclearly shown in FIG. 10A. As shown in FIGS. 9 and 11, slide 62 includesbase 64 with channel 65, and upper platform 66 containing slot 67.Control rod 41 is received through channel 65 and secured to the slide.Alternatively, the slide can be integrally formed with the control rod.Upper platform 66 and slot 67 are oriented both perpendicular to base 64of slide 62 and normal to shaft 81 of slide actuator 80. Pin 86 isreceived and translatable within slot 67, such that rotation of dial 84causes linear translation of slide 62 via pin 86. In this manner, slide62 can be translated away from the distal end of the shaft assemblyuntil the shaft assembly is in the fully open or deployed condition.Further, slot 67 includes notches 68 and 69 which receive the pin whenthe shaft assembly is in the deployed or non-deployed positions,respectively. A threshold rotational force is required to move the pininto slot 67 from either of these two positions. In this manner, theshaft assembly can be locked into either the open, deployed, or theclosed, non-deployed position.

As seen e.g. in FIGS. 4-7, clamping member actuator 70 is likewiserotatably mounted within housing 20 and includes shaft 71 and turn knob72. Shaft 71 is received in opening 22 of housing 20 and retained inplace by flanges 75 and 76 that extend from shaft 71. Shaft 71 includesthreaded portion 74 which threaded onto nut 77. Nut 77 in turn isreceived through slot 33 of clamping member 30 and is also slidablyretained in groove 23 of housing 20 which is oriented parallel to theaxis of shaft 71. Rotation of shaft 71 results in axial movement of nut77 along the shaft, which is translated into pivotal movement ofclamping member 30 about pivot pin 31.

As seen in e.g. FIGS. 1-3, slide actuator 80 and clamping memberactuator 70 are configured for both manual and remote manipulation.Rotation of slide actuator 80 and clamping member actuator 70 can beaccomplished by manual rotation of dial 84 and turn knob 72,respectively. Alternatively, slide actuator 80 and clamping memberactuator 70 are proved with hexagonal sockets 83 and 73, respectively.Socket 83 of slide actuator 80 is located in head 82 of the actuator andaligned with the axis of shaft 81. Similarly, socket 73 of clampingmember actuator 70 is located in turn knob 72 itself and is aligned withthe axis of shaft 71. As shown in FIG. 12, actuator tool 95, whichconsists of handle 96, with shaft 97 having head 98 extending therefrom,can be used to remotely actuate the device. Head 98 of tool 95 isconfigured to engage with sockets 73 and 83. Use of the actuator tool isespecially useful to allow actuation of the device in a crowded surgicalfield where manual actuation may be difficult.

As also shown in e.g. FIGS. 4-7, device 10 includes bleed back tube 91in fluid communication with lumen 42 of control rod 41. Ports 43 and 44are in fluid communication with lumen 42 and exit to the exterior ofcontrol rod 41 at the expandable region of the shaft assembly. Tube 91terminates at luer lock 92 which is capped with plug 93 connected totube 91 through strap 94. In use, observance of a backflow of blood fromthe bleed back tube confirms that the deployed shaft assembly ispositioned within the lumen of the target blood vessel. Further, whenthe device is activated, the suspension of blood blackflow serves as anindicator to the user that an effective seal has been created. In thismanner, the user can check for adequacy of sealing before proceedingwith a grafting procedure. Observance of continued bloodflow afteractivation can be attributable to a poor seal due to e.g. plaque orother defects or anomalies at the target site. The user can thendeactivate the device and move to a different target location. Inaddition, tube 91 also provides an avenue for injecting therapeutic orother materials into vessel, through ports 43 and 44 which again are influid communication with lumen 42.

In the embodiment of FIGS. 1-12, the deployed, expanded shaft assemblytakes on a hexagonal configuration. The invention contemplates otherconfigurations that would be readily discernable to one of skill,provided they provide a contiguous sealing area suitable for use inperforming anastomosis procedures. In variations of the presentinvention, the expanded shaft assembly will be of a configuration thatprovides for a sealed area that is large enough to accommodate multipleanastomoses. Examples of such variations include those depicted in FIGS.13 and 14. FIGS. 13 and 14 depict flexible tube 100 and 150,respectively, which like flexible tube 50 can be incorporated into ashaft assembly for a device according to the present invention. Asshown, tube 100 of FIG. 13 includes bowing portions 101 and 102 deployedinto an octagonal shape. This shape is achieved by including fournotches 105-108 evenly spaced between distal hole 103 and proximal hole104. Similar to the embodiment of FIGS. 1-11, notches 105-108 arefurther configured to ensure formation of the octagonal pattern, withthe respective sides of each notch cut at an angle to one another suchthat as bowing portions 101 and 102 move outwardly, the sides of thenotches come into contact with one another, maintaining the bowingportions at prescribed angles to form an octagon. Tube 150 of FIG. 14includes bowing portions 151 and 152 deployed into an extended hexagonalshape. Similar to the embodiment of FIGS. 1-11, this shape is achievedby providing notches 158 and 159 between distal hole 153 and proximalhole 154, although with notches 158 and 159 being located closer to hole153 or 154, respectively, than each other, such that the sides of thehexagon parallel to the shaft are elongated relative to the other sides.Other possible shapes include circular or oval shapes, which in the caseof flexible tubes as in the embodiments of FIGS. 1-14, can be producede.g. by varying the notching patterns in the bowing portions. Inaddition, any of these shapes can be adjusted to provide for sealedareas that are sufficiently large enough to accommodate multiplegrafting sites. For example, the extended hexagonal shape of FIG. 14 canaccommodate multiple grafting sites. As further detailed below, thisgreatly facilitates multiple anastomosis procedures. A single deploymentof the sealing devices creates a sealed area large enough for multiplegrafts without the need for further repositioning or redeployment of thedevice.

As mentioned, devices according to the present invention are designedfor use, e.g., in an off-pump procedure, with the heart beating andblood flowing through the aorta. The shaft assembly is inserted into theaorta at a location remote from the desired anastomosis site(s) via anintroduction hole created in the aorta according to known methods. Punchhole(s) or aortotomy(ies) are formed at the desired graft (anastomosis)site or sites, using e.g. an arterial punch, either before or after theshaft assembly is internally advanced to the desired site or sites anddeployed. More typically, the hole(s) or aortotomy(ies) are createdafter the device is deployed and a seal is created. Once the device ispositioned, it is actuated to deploy the shaft assembly into itsexpanded, deployed condition and to clamp the clamping member down ontothe expanded region of the shaft assembly, creating a sealed areabetween the sealing membrane of the expanded shaft assembly region andthe vessel wall. Once the seal is created, the graft(s) can be suturedor otherwise attached to the desired site(s), including through the useof automatic suturing devices known in the art. When the procedure(s)are complete, the device is returned to its non-deployed, non-clampingconfiguration and removed from the introduction hole, and the hole issealed.

FIG. 15 shows an embodiment of the invention in use for performing sucha procedure, and in particular, where the single deployment of thedevice provides a seal over an area of the vessel that allows for theperformance of multiple anastomoses. Device 110 is similar to previouslydescribed device 10 but includes shaft assembly 140 that includesflexible tube 150 that forms an elongated hexagonal configuration asshown in FIG. 14. Forks 136 and 137 of clamping member 30 are correspondto the elongated hexagonal configuration of flexible tube 150 in itsexpanded configuration. As shown in operation, shaft assembly 140 hasbeen inserted into hole H created in aorta A and actuated, creating asealed area within the vessel that corresponds to the area encompassedby forks 136 and 137. As depicted, the sealed area is large enough toaccommodate three separate grafts, G1, G2 and G3 without the need tomove, reactuate or otherwise redeploy device 110. Thus multipleanastomoses can be performed with a single placement and actuation ofdevice 110. Alternatively, multiple anasotomoses can be performed usingdevices according to the present invention simply by repositioning theexpandable region at different desired sites but without removing theshaft assembly entirely from the vessel.

FIGS. 16 and 17 show an alternative embodiment of the invention. Device210 is similar in many aspects to device 10, but varies in thedeployment of the expandable region. Shaft assembly 240 includesexpandable shaft 250 encased in deployment tube 241. Expandable shaft250 is formed of a shape memory super-elastic alloy at its distal endregion that can be deformed and retained with tube 241 but which isconfigured to deploy and provide an expandable region upon release fromtube 241. Retraction of tube 241 thus releases shaft 250 and deploys theexpandable region, which consists of three bowing portions 251, 252 and253, with elastomeric membrane 260 spanning the regions between 252 and253 and between 253 and 251. Further, bowing region 253 expands in adirection away from clamping member 230. In use, this creates anexpanded region having a cup-like configuration that creates the seal,and provides additional space for the user to suture the graft with lessrisk of puncturing or tearing the membrane. Tube 241 is configured to berectratable relative to shaft 250 from the closed, non-deployedcondition of FIG. 16 to the open, deployed condition of FIG. 17. Thiscan be accomplished, e.g., by configuring housing 220 of the device toreceive tube 241 and allow for translational movement of tube 241relative to the housing and the fixed shaft 250. Similar mechanisms asused in device 10 can be adapted to actuate tube 241, for example, tube241 can be secured to a slide similar to slide 62 of device 10 and asimilar slide actuation member can be used to cause movement of theslide and tube relative to the shaft and thus deployment of theexpandable region.

FIGS. 18-21 depict additional embodiments of the inventions that providefurther protection to the sealing membrane. In the embodiment of FIGS.18-19, the mid region of protective sheet 61 is translatable alongcontrol rod 41 and is secured at its edges to bowing portions 51 and 52of flexible tube 50. Protective sheet 61 can be made of thin metal,plastic, or reinforced mesh material that is resistant to puncture.Protective sheet 61 is folded accordion-style in the non-deployedcondition (FIG. 18A-19A), and then unfolds to cover the sealing membranein the deployed condition (FIG. 18B-19B). In the embodiment of FIGS.20-21, protective sheet 63 is slidably secured at its mid region alongcontrol rod 41, such that it can translate relative to the control rod,and is formed of a shape memory material again that is resistant topuncture. In the non-deployed condition (FIG. 20A-21A) sheet 63 adopts aconfiguration having two separate rolled-up sections on either side ofrod 41. Upon deployment, the sheet unrolls to its natural configurationand covers the sealing membrane (FIG. 20B-21B). Other methods forprotecting the sealing membrane against tear or puncture are alsocontemplated, including direct reinforcement of the membrane itself,including incorporation of reinforcing mesh into the membrane itself.

While particular embodiments of the invention have been described above,the invention is not intended to be limited to such, but rather oneskilled in the art will recognize that many modifications may be madethat still remain within the scope of the invention, as defined by theappended claims.

1-5. (canceled)
 6. A device for creating a seal in a blood vesselcomprising: a low profile shaft assembly configured for insertion into avessel, said shaft assembly having an expandable region at the distalend of the shaft assembly and a sealing membrane spanning saidexpandable region, said expandable region being deployable from a firstlow-profile position to a second expanded position and having an area inits second expanded position corresponding to an area of a blood vesselthat is large enough to accommodate multiple anastomosis sites, whereinsaid expandable region in its second expanded position has a hexagonalshape; and a clamping member positioned generally opposite to andmoveable towards said expanding region, said clamping member having adistal end shape corresponding to said expanding region in its secondexpanded position.
 7. The device of claim 6 wherein said expandableregion in its second expanded position has an elongated hexagonal shape.8-10. (canceled)
 11. The device of claim 6 wherein said expandableregion further comprises segments that bow outwardly from the shaftassembly when the expandable region is deployed from said firstlow-profile position to said second expanded position.
 12. The device ofclaim 6 wherein at least two of the bowing segments are biased towardthe clamping member when the expandable region is deployed from saidfirst low-profile position to said second expanded position.
 13. Thedevice of claim 11 wherein said bowing segments are formed of a slittedflexible tube.
 14. The device of claim 11 wherein said bowing segmentsare formed of a super-elastic metal memory.
 15. The device of claim 6wherein the sealing membrane is reinforced.
 16. The device of claim 6further comprises a protective shield that is deployable over at least aportion of the expandable region in its second expanded position. 17.The device of claim 6 wherein the shaft assembly further comprises aslide operably linked to said expandable region such that translationalmovement of the slide from a first to a second position deploys saidexpandable region from said first low-profile position to said secondexpanded position.
 18. The device of claim 17 wherein translationalmovement of the slide can be remotely actuated.
 19. The device of claim6 wherein the shaft assembly further comprises a deployment tubemoveable in relationship to the expandable region such thattranslational movement of the deployment tube from a first to a secondposition deploys said expandable region from said first low-profileposition to said second expanded position.
 20. The device of claim 19wherein translational movement of the deployment tube can be remotelyactuated.
 21. A device for creating a seal in a blood vessel comprising:a low profile shaft assembly configured for insertion into a vessel,said shaft assembly having an expandable region at the distal end of theshaft assembly and a sealing membrane spanning said expandable region,said expandable region being deployable from a first low-profileposition to a second expanded position and having a hexagonalconfiguration in its second expanded position; and a clamping memberpositioned generally opposite to and moveable towards said expandingregion, said clamping member having a distal end shape corresponding tosaid expanding region in its second expanded position. 22-37. (canceled)